CC-115 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Multiple clinical trials evaluate CC-115 across advanced solid tumors and hematologic malignancies, such as glioblastoma, castration-resistant prostate cancer, and chronic lymphocytic leukemia. Supported by both pharmaceutical sponsors like Celgene and academic entities such as Memorial Sloan Kettering Cancer Center, these Phase I and Phase II evaluations range from early dose-finding studies to combination regimens with enzalutamide. Current recruitment statuses span from completed clinical investigations to actively recruiting studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02977780	RECRUITING	Glioblastoma	David Reardon, MD	2017-02-09	PHASE2
NCT02833883	COMPLETED	Prostate Cancer; Castration Resistant Prostate Cancer	Memorial Sloan Kettering Cancer Center	2016-07	PHASE1
NCT01353625	COMPLETED	Glioblastoma Multiforme; Squamous Cell Carcinoma of Head and Neck; Prostate Cancer; Ewing's Osteosarcoma; Chronic Lymphocytic Leukemia; Neoplasm Metastasis	Celgene	2011-04-25	PHASE1
NCT01353625	Completed	Glioblastoma Multiforme\|Squamous Cell Carcinoma of Head and Neck\|Prostate Cancer\|Ewing''s Osteosarcoma\|Chronic Lymphocytic Leukemia\|Neoplasm Metastasis	Celgene	2011-04-25	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-19)

Check the CC-115 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

CC-115 acts as a potent dual inhibitor of DNA-dependent protein kinase (DNA-PK, IC50 = 0.013 μM) and mammalian target of rapamycin (mTOR, IC50 = 0.021 μM), simultaneously disrupting non-homologous end joining DNA repair mechanisms and nutrient-sensing mTOR complex signaling cascades. By blocking double-strand break repair and suppressing pro-survival cellular translation, CC-115 impairs tumor cell proliferation and induces apoptosis, underlying its clinical application in trials targeting aggressive neoplasms such as glioblastoma, prostate cancer, and leukemia.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).